The Pediatric Praziquantel Consortium, a consortium dedicated to the development of a new pediatric formulation against schistosomiasis, has received almost $4.9 million from the Japanese Global Health Innovative Technology (GHIT) Fund. The GHIT Fund reaffirms, with this second research grant, its confidence in the work being done by the consortium to offer a treatment solution for pre-school children and the future role that the consortium will be playing for the elimination of schistosomiasis
Schistosomiasis, endemic in 78 developing countries, is a chronic inflammatory disease caused by parasitic worms. According to the World Health Organization, this disease affects at least 249 million people globally, of whom nearly half are children, and commonly is associated with poor sanitation and no access to drinking water. It is one of the most prevalent parasitic diseases in Africa, and one of the most important ones in terms of public health burden and economic impact. Left untreated, this poverty-related disease can lead to anemia, stunted growth, impaired learning ability and chronic inflammation of the organs, which can be fatal in the most serious cases. There is no adequate treatment for children under the age of six, which are estimated to account for about 10% of the global population already infected.
GHIT’s mission is to facilitate international partnerships that bring Japanese innovation, investment and leadership to the global fight against infectious diseases and poverty in the developing world. Dr. Slingsby, CEO and executive director of the GHIT Fund (Japan) said, “There is great need for a formulation of praziquantel created specifically for the pediatric population under six years old. Local healthcare centers and entire communities across Africa and South America (like in Brazil) are faced with a dilemma, where physicians are using an adult formulation for the needs of children. The consortium is working to help fill the gap by developing and registering a formulation for pre-school-age children.”
The existing treatment for schistosomiasis is praziquantel (PZQ), which was developed by Merck, of Darmstadt, Germany, in the 1970s. It is safe and effective, and is available in tablets, suitable for adults and school-age children. Proper treatment of preschool-aged children, including infants and toddlers suffering from schistosomiasis, is hampered due to the lack of a suitable pediatric dosage form that can be readily administered to children. This unmet medical need represents a significant gap toward the main goal of eliminating schistosomiasis. The Pediatric Praziquantel Consortium is working to develop orodispersible (fast disintegrating) tablets for children from three months old to six years old.
This research grant is intended to fund the costs for the conduct of a phase II clinical study in Sub-Saharan Africa, and it also will cover additional costs such as those related to active pharmaceutical ingredient (API) process development activities.
The first research grant from GHIT to the consortium was awarded in 2014 and used to fund the phase I drug development program.